REspiratory diSEAse cohoRt Studies of CHinese Medicine for CAP (RESEARCH- CAP)

The purpose of this study is to evaluate the clinical efficacy and safety of dialectical treatment in the patients with CAP after discharge in a prospective cohort study: one is the Traditional Chinese Medicine (TCM) cohort, which has been evaluated and has certain effects; The other is a non traditional Chinese medicine queue.

Study Overview

• Status: Not yet recruiting
• Conditions: Community Acquired Pneumonia
• Intervention / Treatment: Drug: TCM

Detailed Description

Community acquired pneumonia (CAP) has a high incidence rate, hospitalization rate, case fatality rate and heavy disease burden. The follow-up and post discharge intervention for CAP patients are weak, and they face the risk of re hospitalization or even death due to recurrent pneumonia or other reasons. In clinical practice, more attention has been paid to the improvement of clinical symptoms during hospitalization for patients with CAP, and there is a lack of reports on continued intervention outside the hospital to reduce readmission rates. Therefore, it is necessary to conduct cohort studies on CAP.

This is a multicenter, prospective cohort study aimed at evaluating the clinical efficacy and safety of dialectical treatment for CAP patients. This cohort study will recruit approximately 1078 patients, divided into two cohorts: one is a traditional Chinese medicine cohort, and these patients have been evaluated and have shown certain effectiveness; Another non traditional Chinese medicine cohort, where participants from both cohorts will receive a one-year follow-up period. The main outcome measure is readmission rate. Secondary efficacy indicators include efficacy satisfaction, physician reported outcomes, patient reported outcomes, quality of life ，nutritional status, Acute upper respiratory tract infection (URTI) event, and Survival situation. Follow up every 3 months for 1 year.

• Study Type: Observational
• Enrollment (Estimated): 1078

Contacts and Locations

• Study Contact: Name: Minghang Wang, Doctor; Phone Number: +86 371 66248624; Email: wmh107hn@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

CAP patients

Description

Selection Criteria:

• CAP patients who meet the diagnostic criteria are discharged within 7 days;
• Willing to receive treatment and able to take medication orally;
• Sign an informed consent form.

Exclusion Criteria:

• Patients with confusion, consciousness disorders, dementia, and various mental illnesses;
• Patients with neuromuscular diseases and long-term bed rest who are at risk of aspiration;
• Patients infected with HIV infection or other immunodeficiency diseases;
• Participants in clinical trials of other drugs;
• Known to be allergic to treatment drugs.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
TCM cohort; The main syndromes of discharged CAP patients included in the traditional Chinese medicine queue are Qi deficiency phlegm dampness syndrome and Qi yin deficiency phlegm heat syndrome, mainly referring to the 2011 edition of the "Diagnosis Standards for Traditional Chinese Medicine Syndrome of Community Acquired Pneumonia" issued by the Pulmonary Disease Professional Committee of the Internal Medicine Branch of the Chinese Society of Traditional Chinese Medicine. The exposure factors are the use of modified formulas for tonifying the lungs, strengthening the spleen, and resolving phlegm, or modified formulas for tonifying qi, nourishing yin, and clearing the lungs. Patients with other syndrome types can truthfully record their syndrome types and use traditional Chinese medicine prescriptions.	Drug: TCM; CAP patients diagnosed with Qi Deficiency Phlegm Dampness Syndrome or Qi Yin Deficiency Phlegm Heat Syndrome after discharge, with traditional Chinese medicine treatment as the exposure factor, will be included in the Traditional Chinese Medicine cohort. Patients who continuously take traditional Chinese medicine (modified by Bu Fei Jian Pi Hua Tan Fang or modified by Yi Qi Yang Yin Qing Fei Fang) for more than 2 months per year, or those who intermittently take medicine for more than 3 months of the total time of the year will be classified.
Non TCM queue; CAP patients discharged within 7 days who meet the inclusion and exclusion criteria, and those who do not meet the traditional Chinese medicine queue.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rehospitalization rate	Including all-cause readmission rate and pulmonary infection readmission rate	The Rehospitalization rate within a one-year follow-up period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient satisfaction with efficacy	The Effectiveness Satisfaction Questionnaire of CAP (ESQ-CAP) was used to evaluate the efficacy of pneumonia patients.	Changes in ESQ-COPD relative to baseline at months 3, 6, 9, and 12 during the follow-up phase
Health survey summary table（SF-36）	Using SF-36 to evaluate the impact of CAP on a person's life over time	Changes in SF-36 relative to baseline at months 3, 6, 9, and 12 during the follow-up phase
Clinical outcomes reported by patients	The Patient Reported Outcome for CAP (CAP-PRO) was used to assess the quality of life and health status of patients with pneumonia.	Changes in CAP-PRO relative to baseline at months 3, 6, 9, and 12 during the follow-up phase
Clinical outcomes reported by doctors	The Clinical Reported Outcome for CAP (CAP CRO) was used to assess the patient's condition.	Changes in CAP-CRO relative to baseline at months 3, 6, 9, and 12 during the follow-up phase
nutritional status	Nutritional status related indicators.	Changes in nutritional status of CAP patients relative to baseline at 6 and 12 months of follow-up stage
Acute upper respiratory tract infection (URTI) event	It is a general term for acute inflammation of the nose, pharynx, or throat caused by various viruses and/or bacteria, including common cold, acute viral pharyngitis or laryngitis, acute herpetic pharyngitis, pharyngoconjunctival fever, bacterial pharyngitis, and tonsillitis.	Acute upper respiratory tract infection events that occurred during the one-year follow-up period
Survival situation	Record the number of deaths. Record the follow-up period every 3 months.	Changes in patient survival situation relative to baseline at months 3, 6, 9, and 12 during the follow-up phase

Collaborators and Investigators

• Sponsor: Henan University of Traditional Chinese Medicine
• Collaborators: Shanghai University of Traditional Chinese Medicine; Wuhan No.1 Hospital; Qingdao Haici Hospital; The First Affiliated Hospital of Zhejiang Chinese Medical University; Hebei Provincial Hospital of Traditional Chinese Medicine; Shanxi Traditional Chinese Medicine Hospital
• Investigators: Study Chair: Jiansheng Li, Doctor, The First Affiliated Hospital of Henan University of Traditiona

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: January 5, 2024
• First Submitted That Met QC Criteria: January 22, 2024
• First Posted (Actual): January 23, 2024

Study Record Updates

• Last Update Posted (Actual): April 9, 2024
• Last Update Submitted That Met QC Criteria: April 7, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Treatment Outcome; Medicine, Chinese Traditional; Community Acquired Pneumonia
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Lung Diseases; Pneumonia; Respiration Disorders; Respiratory Tract Diseases
• Other Study ID Numbers: TCM for CAP Cohort

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO